Role of Exercise in PRISm and Subsequent Development of COPD

March 4, 2026 updated by: The University of Hong Kong

Role of Exercise in Functional Capacity of Smokers and Subsequent Development of Chronic Obstructive Pulmonary Disease

Preserved Ratio Impaired Spirometry (PRISm) describes individual with spirometry findings of forced expiratory volume (FEV1) and forced vital capacity (FVC) ratio greater than 0.7 but with the FEV1 less than 80% predicted.

While the spirometry findings of individuals with PRISm can be transited into obstructive pattern, remains at PRISm or become normal spirometry, limited evidence is on the role of exercise in the course of PRISm. This study aims to investigate the role of exercise, namely exercise with telehealth and walking exercise, together with smoking cessation advice, would alter the clinical course of PRISm.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The is an open-labelled prospective randomised control trial on individuals with spirometry findings of PRISm. Individuals who are smoker/ ex-smoker will be screened by spirometry. Eligible individuals who fulfill the inclusion and exclusion criteria will be recruited and randomised into exercise with telehealth group, exercise group and no exercise group into 1:1:1 ratio.

The intervention period is 26 weeks and the follow up period is 52 weeks. In the intervention period, individuals will be instructed to exercise accordingly. In exercise with telehealth group, exercise with telehealth will be performed 2 times per week for 1 hour. In exercise group, individuals will be instructed to have exercise with each week's goal was the lowest of three numbers: (1) the average of the most recent 7 days of step counts + 600 steps, (2) the previous goal + 600 steps, or (3) 10,000 steps per day. In no exercise group, no exercise instruction will be given.

Smoking cessation advice and clincial assessment including hospitalisation due to any respiratory or cardiovascular causes, modified Medical Research Council Dyspnea Scale, St George's Respiratory Questionnaire will be assessed in baseline, week 4, 8, 12, 26, 52. Spirometry by Spirodoc and 6 minute walk test will be assessed at baseline, week 12, 26 and 52.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: King Pui Florence Chan, MD
  • Phone Number: +852 22553741
  • Email: kpfchan@hku.hk

Study Locations

  • China
      • Hong Kong, China
        • Recruiting
        • The University of Hong Kong, Queen Mary Hospital
        • Contact:
          • King Pui Florence Chan, MD
          • Phone Number: +852 22553741
          • Email: kpfchan@hku.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 or above
  • Smoker/ ex-smoker
  • Spirometry shows PRISm, with FEV1/FVC >= 0.7 and FEV1 <80% predicted
  • Ambulatory to walk
  • Able to give informed consent

Exclusion Criteria:

  • Age below 18
  • Non-smoker
  • Spirometry does not show PRISm/ unable to perform spirometry
  • Requires assistance for walking
  • Unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise with telehealth group
Participants will attend telehealth physiotherapy class for exercise. Smoking cessation advice will be given.
Behavioral: Exercise with telehealth group
Participants will attend telehealth physiotherapy class for exercise. Smoking cessation advice will be given.
Active Comparator: Exercise group
Participants will exercise with walking. Smoking cessation advice will be given.
Behavioral: Exercise group
Participants will exercise with walking. Smoking cessation advice will be given.
Active Comparator: No exercise group
No exercise instruction will be given. Participants are encouraged to exercise. Smoking cessation advice will be given.
Behavioral: No exercise group
No exercise instruction will be given. Participants are encouraged to exercise. Smoking cessation advice will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6 minute walk test distance
Time Frame: 1 year
The 6 minute walk test distance will be measured in the start of the study, at 3 months, 6 months and 12 months. The differences will be compared.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Queen Mary Hospital, Hong Kong

Investigators

  • Principal Investigator: King Pui Florence Chan, MD, he University of Hong Kong, Queen Mary Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 24-461

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

According to the current ethics approval protocol, the IPD will be stored anonymously and destroyed 3 years after completion of study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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